Opinion
C. A. N21C-11-055 DJB
12-29-2022
JAMIE YOUNCE, Individually and as Guardian ad litem for her child S.Y., Plaintiff, v. GLAXOSMITHKLINE, LLC, Defendant.
Raeann Warner, Esquire, Jacobs & Crumplar, P.A., Wilmington, Delaware; Jonathan Nace, Esquire, Nidel & Nace, LLP, Rockville, Maryland (admitted pro hac vice) for Plaintiffs. Brian Rostocki, Esquire, and Justin Forcier, Esquire, Reed Smith, LLP, Wilmington, Delaware; Andrew Bayman, Esquire, TaCara Harris, Esquire, Meredith Redwine, Esquire, and Aaron Parks, Esquire, King & Spalding, LLP, (admitted pro hac vice) Atlanta, Georgia; for Defendants.
On Defendant Glaxosmithkline LLC's Motion to Dismiss - GRANTED in part; DENIED in part.
Raeann Warner, Esquire, Jacobs & Crumplar, P.A., Wilmington, Delaware; Jonathan Nace, Esquire, Nidel & Nace, LLP, Rockville, Maryland (admitted pro hac vice) for Plaintiffs.
Brian Rostocki, Esquire, and Justin Forcier, Esquire, Reed Smith, LLP, Wilmington, Delaware; Andrew Bayman, Esquire, TaCara Harris, Esquire, Meredith Redwine, Esquire, and Aaron Parks, Esquire, King & Spalding, LLP, (admitted pro hac vice) Atlanta, Georgia; for Defendants.
MEMORANDUM OPINION
BRENNAN, J.
I. Background
This suit arises from Plaintiff Jamie Younce's (hereinafter "Younce") use of Paxil, a prescription anti-depressant, while pregnant, resulting in alleged injuries to her and her child, Plaintiff S.Y. (hereinafter "S.Y.") Defendant Glaxosmithkline, LLC (hereinafter "GSK"), was the manufacturer of Paxil. Paxil is an antidepressant and anti-anxiety drug that belongs to a group of drugs called selective serotonin reuptake inhibitors (SSRIs).
Jamie Younce proceeds individually and as guardian ad litem for her child S.Y.
Am. Compl. ¶ 4, Feb. 14, 2022 (D.I. 12).
Id. ¶ 10.
Plaintiffs allege that Younce was prescribed and used Paxil as directed, including during all three trimesters of her pregnancy. S.Y. was born on November 27, 2002, and it is alleged that as a consequence of taking Paxil, S.Y. suffers from "irreversible brain damage," which "manifest[s] as severe behavioral, neurologm ical and emotional injuries." The Amended Complaint details how SSRIs function and references scientific studies purportedly linking SSRIs to an increased risk of autism and autism spectrum disorder ("ASD").
Id. ¶ 9.
Id. ¶ 9, 69.
Id. ¶¶ 15-62.
In their suit against GSK, Plaintiffs assert common law claims for: Strict Products Liability (Count I); Negligence (Count II); Gross Negligence (Count III); Breach of Implied Warranty (Count IV); Breach of Express Warranty (Count V); Negligent Misrepresentation and Fraud (Count VI). Plaintiff also asserts statutory claims under Ohio's Product Liability Act ("OPLA"): Strict Products Liability Design Defect-O.R.C. § 2307.75 (Count VII); Strict Products Liability Due to Inadequate Warning-O.R.C. § 2307.76 (Count VIII); Strict Products Liability Nonconformance with Representations-O.R.C. § 2307.77 (Count IX). Plaintiff also seeks punitive damages.
Id. ¶¶ 73-138.
Id. ¶¶ 139-183.
Id. ¶ 185.
The case was originally filed on July 9, 2020. GSK moved to dismiss the initial Complaint. In lieu of further briefing, the parties stipulated to the filing of an Amended Complaint on January 6, 2021. Thereafter, GSK moved to dismiss the Amended Complaint. During briefing, Plaintiffs stipulated to dismiss some of their claims, but opposed dismissal as to the others. After briefing was complete, the Court ordered Plaintiffs to file a Second Amended Complaint to reflect the stipulated dismissal, which Plaintiffs filed on April 20, 2021. Defendant then filed its motion to dismiss the Second Amended Complaint.
N20C-06-231 DJB - D.I. No. 1.
N20C-06-231 DJB - D.I. No. 23.
N20C-06-231 DJB - D.I. Nos. 28.
N20C-06-231 DJB - D.I. No. 35.
N20C-06-231 DJB - D.I. No. 38.
N20C-06-231 DJB - D.I. Nos. 43-44.
N20C-06-231 DJB - D.I. No. 47. Shortly after briefing was complete on Defendant's motion to dismiss the Second Amended Complaint, a new judicial officer was assigned. D.I. No. 52.
Initially, this case was filed in conjunction with the claims of another Plaintiff and her child and choice of law for each respective sets of Plaintiffs was to be determined by the Court. However, the parties eventually stipulated that the law of Plaintiffs' respective home state should apply to that individual Plaintiff's claims.Accordingly, the Court ordered that the parties should sever the action and file a new Complaint in accordance with applicable state law in each docket. The parties have agreed that Ohio law applies to the Younce Plaintiffs here.
N20C-06-231 DJB - D.I. No. 58.
Id.
Pursuant to the Court's Order, the Younce Plaintiffs filed another Amended Complaint on November 4, 2021. Thereafter, on February 2, 2022, the parties stipulated to the filing of the most recent and operative Amended Complaint, which Plaintiff submitted on February 14, 2022. GSK filed the instant motion to dismiss on March 16, 2022; oral argument was subsequently held. This is the Court's decision on GSK's motion to dismiss.
N21C-11-055 DJB - D.I. No. 1.
N21C-11-055 DJB - D.I. Nos. 10-12.
N21C-11-055 DJB - D.I. Nos. 14 & 28.
II. Standard of Review
"Under Superior Court Civil Rule 12(b)(6), the legal issue to be decided is, whether a plaintiff may recover under any reasonably conceivable set of circumstances susceptible of proof under the complaint." Under that Rule, the Court must:
Vinton v. Grayson, 189 A.3d 695, 700 (Del. Super. 2018) (quoting Superior Court Civil Rule 12(b)(6)).
(1) accept all well pleaded factual allegations as true, (2) accept even vague allegations as "well pleaded" if they give the opposing party notice of the claim, (3) draw all reasonable inferences in favor of the non-moving party, and (4) not dismiss the claims unless the plaintiff would not be entitled to recover under any reasonably conceivable set of circumstances.
Id. (quoting Cent. Mortg. Co. v. Morgan Stanley Mortg. Capital Hldgs. LLC, 27 A.3d 531, 535 (Del. 2011)) (citing Prince v. E.I. DuPont de Nemours & Co., 26 A.3d 162, 166.
"The Court, however, need not accept conclusory allegations unsupported by specific facts or … draw unreasonable inferences in favor of the non-moving party." "If any reasonable conception can be formulated to allow Plaintiffs' recovery, the motion must be denied."
Intermec IP Corp. v. TransCore, LP, 2021 WL 3620435, at *11 (Del. Super. Ct. Aug. 16, 2021) (citing Prince v. E.I. DuPont de Nemours & Co., 26 A.3d 162, 166 (Del. 2011), overruled on other grounds by Ramsey v. Ga. S. Univ. Advanced Dev. Ctr., 189 A.3d 1255, 1277 (Del. 2018)).
Vinton, 189 A.3d at 700 (citing Cent. Mortg. Co., 27 A.3d at 535).
Under Superior Court Civil Rule 9(b) "all averments of fraud, negligence, or mistake … shall be stated with particularity." "The particularity requirement embodied in Rule 9(b) operates to: (1) provide defendants with enough notice to prepare a defense; (2) prevent plaintiffs from using complaints as fishing expeditions to unearth wrongs to which they had no prior knowledge; and (3) preserve a defendant's reputation and goodwill against baseless claims."
Del. Super. Ct. Civ. R. 9(b).
In re Benzene Litig., 2007 WL 625054, at *6 (Del. Super. Ct. Feb. 26, 2007).
III. Discussion
GSK moves to dismiss the Amended Complaint on two grounds, first that the Amended Complaint fails to satisfy Delaware's pleading standard and should be dismissed in its entirety with prejudice. Second, that all of Plaintiffs' claims, except Count VIII, fail under Ohio law, including the request for punitive damages.
A. The Amended Complaint Provides Adequate Notice Under Delaware's Pleading Standard
GSK contends that the Amended Complaint is conclusory and fails to "plead the most basic facts to support [the asserted] claims." Specifically, GSK asserts that the Amended Complaint fails to allege facts regarding: 1) Younce's decision to use Paxil and what warnings or representations she or her doctors relied upon; 2) when GSK knew or should have known of the alleged defect in Paxil, whether this knowledge preceded Younce's use of Paxil, and what specific warnings were given at the time Younce took Paxil; 3) the specific nature of S.Y.'s alleged injuries; and 4) scientific data showing causal link between Paxil and the alleged injuries. GSK further argues that allegations discussing anti-seizure medication and referencing epilepsy are wholly irrelevant considering Paxil is an antidepressant.
Def.'s Opening Br. at 4, Mar. 16, 2022 (D.I. 70).
Id. at 4-5.
Id. at 5-6. GSK also takes issue with certain references to scientific studies made in the Complaint and what it alleges are misquotes from its Paxil label. Id. at 6-7.
Plaintiffs assert the Amended Complaint is well-pled and maintains that the warnings on the Paxil label were inadequate "regarding its use during pregnancy and the risk of permanent, irreversible damage to the developing brain." Plaintiffs further argue the Amended Complaint sufficiently pled when the harm occurred.Moreover, Plaintiffs argue their most recent Complaint "specifically" refers to S.Y.'s injuries as "irreversible brain damage" and Delaware's pleading standard does not require anything more. Finally, Plaintiffs argue the scientific literature cited and referenced in the Amended Complaint addresses the causal link between "SSRI medications and the development of irreversible brain damage."
Pl.'s Opp'n Br. at 3, Apr. 8, 2022 (D.I. 18).
Id.
Id.
Id. at 3-4.
Here, Plaintiffs sufficiently allege claims to provide GSK with adequate notice to prepare a defense. Plaintiffs allege that S.Y. was born on November 27, 2002, and that Younce was prescribed and took Paxil during all three trimesters of her pregnancy. Plaintiffs further allege that Paxil's label and warnings were inadequate "regarding its use during pregnancy and the risk of permanent, irreversible damage to the developing brain." Plaintiffs maintain that GSK knew or should have known of the risks using Paxil posed to pregnant women, and as a result of its failure to warn the medical community, including the medical professionals who prescribed Paxil to Younce, both Plaintiffs would have avoided injury.
Am. Compl. ¶¶ 8-9.
Id. ¶ 76.
Id. ¶¶ 63, 65-67; 92.
Though the allegations regarding the specific nature of the alleged injury may be vague, GSK does not cite to, nor has the Court found, any authority requiring Plaintiffs to plead a specific diagnosis or ailment. Plaintiffs do allege that Paxil is defective and provided the timeframe in which Younce allegedly took Paxil, and that taking Paxil while pregnant caused injuries to S.Y. in the form of "irreversible brain damage." Plaintiffs reference and cite to various studies linking SSRIs, a class of drug to which Paxil belongs, to neurodevelopmental harm. Such claims are sufficient under the reasoning in this court's decision in In re Benzene and defendant is sufficiently on notice of the claims. The Complaint similarly provides notice of the product alleged to have caused the harm, sufficient notice of injuries for this stage in the litigation and how and when the alleged harm occurred. This is what Plaintiffs have done here.
Am. Compl. ¶¶ 9, 64-67.
Id. ¶ 9.
Id. ¶¶ 15-62. GSK takes issue with Plaintiff's reliance on scientific studies which purportedly link SSRIs generally to neurodevelopmental injury. Def.'s Opening Br. at 6. However, Paxil is classified as an SSRI drug, and at the pleading stage, such allegations supporting a causal relationship between Paxil and alleged injuries are sufficient to withstand a motion to dismiss.
In re Benzene, 2007 WL 625054, at *14 (Del. Super. Ct. Feb. 26, 2007) (in reviewing a products liability complaint, finding the complaint at issue failed to sufficiently plead a claim against some defendants but met its burden as to others, reasoning in part that the narrow time frame and the focused class of products permitted the defendant to develop an adequate defense.)
Id. See also Hupan v. All. One Int'l., Inc., 2015 WL 7776659, at *11-12 (Del. Super. Ct. Nov. 30, 2015) (finding mere allegations of "other products" and "other pesticides" as defective was insufficient to meet Delaware's pleading standard and dismissed a complaint on the basis that the defendant lacked "adequate notice regarding what products caused the harm, the cause of Plaintiffs' injuries, how they occurred or when the harm occurred.).
That said, the Amended Complaint is not without flaw. The Amended Complaint references seizure medications and epilepsy numerous times despite the apparent irrelevance to the underlying case. At argument, Plaintiffs acknowledged such references were typos and submitted a highlighted copy of the Amended Complaint identifying all typographical errors. GSK seeks dismissal with prejudice for, among other things, Plaintiffs' repeated failure to amend all deficiencies in the Amended Complaint. This Court has twice previously ordered Plaintiffs to amend the pleadings; once, after the parties stipulated to a partial dismissal, and then again, when two separate dockets were created. However, while the Court is sympathetic to GSK's position, consistent with Delaware public policy, Plaintiffs will be given one final opportunity to amend the Complaint to correct the identified deficiencies. However, despite these flaws, Plaintiffs have adequately pled that GSK's product was defective and as a result, caused harm and have sufficiently put GSK on notice to prepare an adequate defense.
Id. ¶¶ 120, 127, 132, 134, 150, 168, 178-79.
N21C-11-055 DJB-D.I. 30.
Def.'s Opening Br. at 9 n.7 ("Plaintiff has already been given [the opportunity to add supplemental facts] four times but has chosen not to act. Plaintiff should not get a fifth bite at the apple.").
N20C-06-231 DJB-D.I. No. 43.
N20C-06-231 DJB-D.I. No. 58.
See Waterhouse v. Hollingsworth, 2013 WL 5803136, at *3 (Del. Super. Ct. Oct. 10, 2013) (citing Keener v. Isken, 58 A.3d 407, 409 (Del. 2013)).
B. Common Law Claims
GSK moves to dismiss Plaintiffs common law claims, arguing that the Ohio Products Liability Act ("OPLA") applies and thus abrogates Counts I-VI. OPLA applies to "any recovery of compensatory [or punitive] damages based on a product liability claim." OPLA defines a product liability claim, in pertinent part, as follows:
Id.
[A] claim or cause of action that is asserted in a civil action pursuant to sections 2307.71 to 2307.80 of the Revised Code and that seeks to recover compensatory damages from a manufacturer or supplier for death, physical injury to person, emotional distress, or physical damage to property other than the product in question, that allegedly arose from any of the following:
(a) the design, formulation, production, construction, creation, assembly, rebuilding, testing, or marketing of that product;
(b) Any warning or instruction, or lack of warning or instruction, associated with the product;
(c) Any failure of that product to conform to any relevant representation or warranty.
Id. § 2307.71(13).
OPLA applies to injuries resulting from the use of an "ethical drug," which is defined as "prescription drugs that are prescribed or dispensed by a physician or any person who is legally authorized to prescribe or dispense a prescription drug."Plaintiffs allege that Younce was prescribed Paxil by a medical professional; as a result, the Court must find that Paxil is an "ethical drug," as it fits squarely within the OPLA definition. Moreover, the Amended Complaint alleges physical and emotional injuries stemming from Younce's use of Paxil. Accordingly, Plaintiffs claims fall within OPLA's definition of products liability claims.
Id. § 2307.71(A)(4). The United States District Court of the Southern District of Ohio has specifically applied OPLA to a products liability claim involving Paxil. See Stratford v. SmithKline Beecham Corp., 2008 WL 2491965, at *3 (S.D. Ohio June 17, 2008).
Am. Compl. ¶¶ 8, 63, 92.
Id. ¶¶ 181-82.
On April 7, 2005, the Ohio General Assembly amended OPLA to "abrogate all common law product liability causes of action." Ohio law has interpreted the abrogation amendment not to apply retroactively, with a cutoff date of April 7, 2015. The parties dispute, however, which date controls for purposes of the OPLA: the date Plaintiffs were injured (the date the claim "arose") or the date Plaintiffs realized or should have realized the injury was caused by Paxil (the "accrual date"). Plaintiffs allege that their injury arose in 2002, but claimed the damages were not discovered until after the passage of OPLA.
See Doty v. Fellhauer Elec., Inc., 888 N.E.2d 1138, 1142 (6th Dist. Oh. 2008).
Am. Compl. ¶ 73.
Id. ¶ 139. Plaintiffs do not provide a specific date as to when she discovered damages, only that it was discovered after the passage of OPLA. However, the Ohio General Assembly passed OPLA in 1988, but did not pass the abrogation amendment until April 7, 2005. Therefore, although not argued by either party, Plaintiffs' claims potentially could have accrued after the passage of OPLA but before passage of the abrogation amendment.
Unfortunately, there is no controlling authority on the question of which date to apply, as there is a split in authority in the Ohio Courts who have faced this issue.The Ohio Courts who favor applying the accrual date, cite to Section 2305.10 of Ohio's Revised Code. Section 2305.10(B)(1) applies the discovery rule exception to the statute of limitations to products liability claims caused by exposure to ethical drugs. Under Ohio law, the statute of limitations typically "begins to run at the time the wrongful act was committed;" however, the discovery rule tolls the statute of limitations "until the plaintiff discovers, or by the exercise of reasonable diligence should have discovered, that he or she was injured by the wrongful conduct of the defendant." In addition, the court in Hutchens v. Abbot Laboratories, Inc. noted that Section 2305.10 is titled "Product Liability, bodily injury or injury to personal property: when certain causes of action arise." As a result, these courts reasoned that the accrual date applied in determining whether OPLA abrogated common law products liability claims.
The following courts have held that the accrual date applies to determine whether a common law claim is abrogated under OPLA. E.g., Hutchens v. Abbott Laboratories, Inc., 2016 WL 5661582, at *10-11 (N.D. Ohio Sept. 30, 2016); Hempy v. Breg, Inc., 2012 WL 380119, at *2 (S.D. Ohio Feb. 6, 2012); Musgrave v. Breg, Inc., 2011 WL 5299489, at *3-4 (S.D. Ohio Nov. 4, 2011); Deacon v. Apotex, Corp., 2008 WL 2844652, at *4 (S.D. Ohio July 22, 2008); Stratford, 2008 WL 2491965, at *3. Other courts, however, have held that the date the injury arose is the trigger date to determine abrogation. E.g., Kiker v. Smithkline Beecham Corp., 2015 WL 5768389, at *3-5 (S.D. Ohio Sept. 30, 2015); Liming v. Stryker Corp., 2012 WL 1957287, at *3 (S.D. Ohio May 31, 2012); Edwards v. Warner-Lambert, 2011 WL 5914008, at *5 (S.D. Ohio Nov. 28, 2011); Troyer v. I-Flow Corp., 2011 WL 2517031, at *4 (S.D. Ohio June 23, 2011).
Hutchens v. Abbott Laboratories, Inc., 2016 WL 5661582, at *11 (N.D. Ohio Sept. 30, 2016) (citing Norgard v. Brush Wellmann, Inc., 766 N.E.2d 977, 979 (Ohio 2002).
Id.
The court in Musgrave v. Breg, Inc. found additional support for utilizing the accrual date. Musgrave held that Ohio law does not recognize a "meaningful distinction between a claim 'arising' or 'accruing.'" The Musgrave court cited to Browning v. Burt, an Ohio Supreme Court decision, which noted that "the terms 'arose' and 'accrued' are synonymous…" As a result of these factors, these courts rely on the accrual date as the operative date for abrogation purposes.
See Musgrave, 2011 WL 5299489, at *4.
Id.
Id. (quoting Browning v. Burt, 613 N.E.2d 993, 1004 (Ohio 1993)).
Courts that applied the date the claim arose reasoned that the discovery rule for statute of limitations purposes is distinct from the triggering date for an abrogation analysis under OPLA. These courts have held that "[u]ltimately the issue is whether the initial injury took place before the amendment to the OPLA on April 7, 2005…" The District Court in In re: E. I. Du Pont De Nemours and Company C-8 Personal Injury Litigation found the reasoning in Musgrave, that Ohio law considered the terms "arose" and accrue" synonyms, distinguishable. In Browning v. Burt, the Ohio Supreme Court made that determination in analyzing two different statutes of limitations. The Du Pont court found, in that context, the two terms are indistinguishable, and found that a distinction between the two terms exists when imposing "a discovery rule into the determination of whether the Ohio Tort Reform Act applies to a cause of action."
See Kiker, 2015 WL 5768389, at *4; Liming, 2012 WL 1957287, at *3; Troyer, 2011 WL 2517031, at *4.
Troyer, 2011 WL 2517031, at *4.
In re: E. I. Du Pont De Nemours and Company C-8 Personal Injury Litig., 2016 WL 659112, at *71 (S.D. Ohio Feb. 17, 2016).
Browning, 613 N.E.2d at 1004.
In re: E. I. Du Pont De Nemours and Company C-8 Personal Injury Litig., 2016 WL 659112, at *71.
Id. at *72.
The most logical approach here is to adopt the accrual date in determining whether to abrogate common law claims under OPLA. Ohio law appears, at least in the context of a product liability claim, to treat when a claim accrues and when a claim arises interchangeably. Section 2305.10(B)(1) of the Ohio Revised Code applies the discovery rule to products liability claims stemming from exposure to ethical drugs. That Section's title expressly states, "…when certain causes of action arise." Although Plaintiffs argue that when claims "arise" and "accrue" are distinct concepts, no controlling authority is cited to support this proposition. By contrast, the Ohio Supreme Court in Browning, albeit in a somewhat different context, and Section 2305.10 of Ohio's Revised Code appear to use the terms synonymously.
Id.
Id. § 2305.10(B)(1); Browning, 613 N.E.2d at 1004.
It is undisputed that under Ohio law, a product liability claim involving ethical drugs accrues when a plaintiff knows or reasonably should know that their injury stemmed from exposure to the drug. Following that reasoning, the applicability of the accrual date is the controlling date. To find otherwise could lead to inequitable results where a plaintiff tolls their claim for statute of limitation purposes but seeks to apply more favorable law that existed when his or her injury occurred.Accordingly, the Court finds that OPLA's abrogation amendment was in effect when Plaintiff's claims accrued, and as a result, Plaintiff's common law product liability claims are abrogated as a matter of law.
See Musgrave, 2011 WL 5299489, at *3 ("Breg argues that, once Plaintiffs elected to use the accrual analysis of the discovery rule to avoid the bar of the statute of limitations, they should not be heard to simultaneously claim that their request for non-economic damages should be governed under more favorable law that was in effect only before their causes of action accrued.").
C. OPLA Claims
In the alternative to the common law counts, Plaintiffs alleges three claims under OPLA: Count VII-Strict Products Liability Design Defect (O.R.C. § 2307.75); Count VIII-Strict Products Liability Due to Inadequate Warning (O.R.C. § 2307.76); Count IX-Strict Products Liability Nonconformance with Representations (O.R.C. § 2307.77). GSK moves to dismiss all but Plaintiffs' inadequate warning claim (Count VIII), for failure to state a claim upon which relief can be based.
Am. Compl. ¶ 139.
1. Count VII is Recognized Under OPLA and Sufficiently Pled
GSK argues that Plaintiffs' design defect claim under O.R.C. § 2307.75 fails for three reasons: (1) Ohio law does not recognize design defect claims involving prescription drugs; (2) Plaintiff has not pled a feasible alternative design or formulation; and (3) design defect claims involving prescription drugs under state law are pre-empted by federal law.
O.R.C. § 2307.75(A) provides that "a product is defective in design or formulation if, at the time it left the control of its manufacturer, the foreseeable risks associated with its design or formulation . . . exceeded the benefits associated with that design or formulation[.]" Subsections (D) and (F) provide two pertinent exceptions to subsection (A). Under O.R.C. § 2307.75(D), a prescription drug "is not defective in design or formulation because some aspect of it is unavoidably safe, if the manufacturer . . . provides adequate warning . . . concerning that unavoidably unsafe aspect." Subsection (F) states "[a] product is not defective in design or formulation if, at the time the product left the control of its manufacturer, a practical and technically feasible alternative design or formulation was not available that would have prevented the harm for which the claimant seeks to recover…"
Id. § 2307.75(D).
Id. § 2307.75(F).
a. Ohio Law Recognizes Design Defect Claims Involving Prescription Drugs.
Section § 2307.75(D) explicitly carves out a safe harbor from design defect liability for drug manufacturers where the drug in question is "unavoidably safe, if the manufacturer . . . provides adequate warning." If design defect claims involving prescription drugs were not recognized under Ohio law, subsection (D)'s safe harbor would be meaningless. Plaintiffs allege that the risks associated with the use of Paxil outweighs its benefits, and Paxil "failed to provide adequate warning and instruction concerning the unavoidably unsafe aspect of Paxil."
Id. § 2307.75(D).
Am. Compl. ¶ 148.
GSK cites Ohio case law in support of their motion, but the cited authority is distinguishable. The Court in Monroe v. Novartis Pharmaceuticals Corporation, at the summary judgment stage, found that plaintiffs' design defect claim involving a prescription drug failed because plaintiffs did not present evidence showing the drug's risks outweighed its benefits. Given the fact that the Monroe court looked at this claim under a summary judgment standard following discovery, the court was able to evaluate plaintiffs' design defect claim on its merits. Having found on the record before it in that case that the plaintiff failed to produce sufficient evidence to survive summary judgment, the claim was dismissed. Monroe does not stand for the proposition that a design defect claim for a prescription drug necessarily fails under OPLA. In Aaron v. Medtronic, Inc., the District Court of the Southern District of Ohio evaluated a design defect claim involving a medical device, not a prescription drug. The court, in examining FDA regulations pertaining to medical devices, determined that the plaintiffs' claims were expressly and impliedly pre-empted by federal law. The U.S. Supreme Court has distinguished FDA regulations regarding prescription drugs and medical devices, and without more, the Aaron case is inapposite to Plaintiffs' design defect claim here.
Monroe v. Novartis Pharm. Corp., 29 F.Supp.3d 1115, 1124 (S.D. Ohio 2014).
Id.
Aaron v. Medtronic, Inc., 209 F.Supp.3d 994, 997 (S.D. Ohio 2016) (identifying defendant's product, Infuse, as a medical device "used to stimulate spinal growth in spinal fusion surgeries.").
Id. at 1007-08, 1101.
Wyeth v. Levine, 555 U.S. 555, 574 (2009) ("But despite [Congress's] 1976 enactment of an express pre-emption provision for medical devices, Congress has not enacted such a provision for prescription drugs.") (internal citations omitted).
b. Plaintiffs have sufficiently pled a feasible alternative design.
GSK further argues that Plaintiffs' design defect claim fails as a matter of law because Plaintiff has not adequately pled a feasible alternative design. Under O.R.C. § 2307.75(F), a plaintiff has the burden to prove a feasible alternative design that would have prevented the alleged injury. Here, Plaintiffs have pled that there were safer, alternative designs available to treat depression. Plaintiffs have also pled that alternative formulations for other medications were available. As a result, at this stage in litigation, Plaintiffs have adequately pled a feasible alternative design.
Monroe, 29 F.Supp.3d at 1124 (citing McGrath v. Gen. Motors Corp., 26 Fed.Appx. 506, 510 (6th Cir. 2002)).
Am. Compl. ¶ 149.
Id. ¶ 150. Though Plaintiffs refer to alternative formulations of anti-seizure drugs, this is one of many typos Plaintiffs have identified and intends to correct. See N21C-11-055 DJB - D.I. 30.
c. Plaintiff's design defect claim is not pre-empted by federal law.
GSK argues that Plaintiffs' design defect claim under Ohio law is preempted by federal law pursuant to Mutual Pharmaceutical Company, Inc. v. Bartlett. In Bartlett, the United States Supreme Court held that "New Hampshire's warning-based design-defect cause of action" was pre-empted by federal law. The New Hampshire law at issue imposed a "risk-utility approach" to design-defect liability premised on three main factors: 1) the product's usefulness and desirability; 2) the ease and cost of mitigating the product's risk of danger; and 3) the adequacy of the product's warning. At trial, the jury "was presented with evidence relevant to, and was instructed to consider" the adequacy of the drug's label in determining whether the drug was defective. The defendant in Bartlett was a generic drug manufacturer, which, under federal law, prevented the defendant from unilaterally redesigning the formulation of its drug or changing the drug's label. Accordingly, the Court determined that it was impossible for the defendant drug manufacturer "to comply with both state and federal law" and held that New Hampshire's design-defect law was "pre-empted with respect to FDA-approved drugs sold in interstate commerce."
570 U.S. 472 (2013).
Id. at 487.
Id. at 483 ("the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product's effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses.")
Id. at 486.
Id. at 483-84, 486.
Id. at 486-87.
Bartlett, however, is distinguishable from the instant matter as it dealt with a generic drug as opposed to a brand-name drug, like Paxil. In determining that the defendant could not alter its drug label under federal law, the Bartlett Court relied on its decision in PLIVA, Inc. v. Mensing. In Mensing, the United States Supreme Court distinguished the labeling duties between brand-name and generic drug manufacturers. Specifically, the Court found:
Id. at 475 ("We must decide whether federal law pre-empts the New Hampshire design-defect claim under which respondent Karen Bartlett recovered damages from petitioner Mutual Pharmaceutical, the manufacturer of sulindac, a generic nonsteroidal anti-inflammatory drug.") (emphasis added).
See id. at 486 (citing PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011)).
See Mensing, 564 U.S. at 613.
As a result, brand-name and generic drug manufacturers have different federal drug labeling duties. A brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its label. A manufacturer seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the same as the brand name's.
Id. (internal citations omitted).
Based on this distinction in labeling requirements, the Bartlett Court found that it was impossible for generic drug manufacturers to "tak[e] the remedial action required to avoid liability under New Hampshire law." Unlike the drug at issue in Bartlett and Mensing, Paxil is a brand-name drug, and GSK, as its manufacturer, "is responsible for the accuracy and adequacy of its label." Bartlett is distinguishable from the instant matter and does not require Federal law to pre-empt Ohio's design defect law in this matter.
See Bartlett, 570 U.S. at 486.
Mensing, 564 U.S. at 613. Compare Wyeth, 555 U.S. at 573 (holding that FDA regulations permitted defendant, a brand-name drug manufacturer, to "unilaterally strengthen its warning"), with Mensing, 564 U.S. at 614 (finding that FDA regulations permit "changes to generic drug labels only when a generic drug manufacturer changes its label to match an updated brand-name label or to follow the FDA's instructions.").
GSK similarly relies on the United States District Court of the Southern District of Ohio's opinion in Rheinfrank v. Abbott Laboratories, Inc. In Rheinfrank, the District Court found that design defect claims brought in that case under OPLA were pre-empted under Bartlett. Rheinfrank, relying on the rationale of a sister district court, concluded that Bartlett applies equally to pre-empt generic and brand-name drugs alike. The court specifically relies on one sentence in Bartlett, "[o]nce a drug-whether generic or brand-name-is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including inactive ingredients, or in the specifications provided in the approved application." A careful reading of Bartlett, however, indicates that this sentence refers to altering the composition of an FDA-approved drug. In fact, the very next sentence of the Bartlett opinion reads "[g]eneric manufactures are also prohibited from making any unilateral changes to a drug's label." Ohio law imposes design-defect liability upon drug manufacturers, for among other things, having an inadequate label, which has been pled by Plaintiffs here. Moreover, as explained above, prior United States Supreme Court precedent has distinguished federal pre-emption as to state tort law claims between generic and brand-name drug manufacturers. Accordingly, the Plaintiffs' design defect claim is sufficient to withstand GSK's motion to dismiss.
Rheinfrank v. Abbott Labs, Inc., 137 F.Supp.3d 1035, 1041 (S.D. Ohio 2015).
Id.
Id. (quoting Bartlett, 570 U.S. at 477).
Bartlett, 570 U.S. at 477.
Id. (emphasis added).
Am. Compl. ¶ 148.
Compare Wyeth, 555 U.S. at 573 (holding that FDA regulations permitted defendant, a brand-name drug manufacturer, to "unilaterally strengthen its warning"), with Mensing, 564 U.S. at 614 (finding that FDA regulations permit "changes to generic drug labels only when a generic drug manufacturer changes its label to match an updated brand-name label or to follow the FDA's instructions.").
2. Count IX is sufficiently pled
GSK argues that Count IX of the Amended Complaint should be dismissed because Plaintiffs failed to allege specific representations upon which Younce relied upon while taking Paxil. In addition, GSK contends that Paxil's label, at the relevant time, did not warrant absolute safety. Plaintiffs assert that this claim is not based on an absolute warranty of safety, but rather GSK's representation that Paxil's benefits could outweigh its risks for women who are pregnant or could become pregnant.
Def.'s Opening Br. at 13.
Id.
Pl.'s Opp'n Br. at 10.
Under O.R.C. § 2307.77, "[a] product is defective if it did not conform, when it left the control of its manufacturer, to a representation made by that manufacturer. A product may be defective because it did not conform to a representation even though its manufacturer did not act fraudulently, recklessly, or negligently in making the representation." OPLA defines a "representation" as "an express representation of a material fact concerning the character, quality, or safety of a product." To recover under O.R.C. § 2307.77, "a plaintiff must show that (1) the manufacturer made a representation as to a material fact relating to the character or quality of the product; (2) the product did not conform to that representation; (3) the plaintiffs justifiably relied on that representation; and (4) the plaintiffs' reliance on the representation was the direct and proximate cause of the plaintiffs' injuries."
Id. § 2307.71(14).
Tolliver v. Bristol-Meyers Squibb Co., 2012 WL 3074538, at *5 (N.D. Ohio July 30, 2012) (citing Saraney v. TAP Pharm. Prods., Inc., 2007 WL 148845, at *8 (N.D. Ohio Jan. 16, 2007)).
Paxil's 2002 label stated, in relevant part, that "[t]here are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus." In the Amended Complaint, Plaintiffs allege that GSK, through Paxil's product label, represented that "the benefits of Paxil in treating depressive disorders could outweigh the risk even for women of childbearing years." Although Paxil's label does not explicitly state that the benefits of Paxil could outweigh its risks, this allegation is nonetheless sufficient. At the motion to dismiss stage, the Court is required to accept all well-pled allegations as true and draw all reasonable inferences in favor of the non-movant. The Complaint alleges that the 2002 label stated, "this drug should be used during pregnancy only if the potential benefit justifies the potential risk," and the Court is bound to draw all reasonable inferences in Plaintiffs' favor.
Def.'s Opening Br., Ex. B at 15 (emphasis added). This Court may take judicial notice of publicly available FDA labels without converting the motion to dismiss into one for summary judgment. Camejo v. Angelini Pharma Inc., 2021 WL 141338, at *3 (Del. Super. Ct. Jan. 15, 2021) (citing Machala v. Boehringer Ingenheim Pharm., Inc., 2017 WL 2814728, at *7 n.69 (Del. Super. Ct. June 29, 2017)).
Am. Compl. ¶ 176 (emphasis added).
Vinton, 189 A.3d at 700.
Plaintiffs have, at this stage, sufficiently alleged that the representation made does not conform with Paxil. In paragraph 63 of the Amended Complaint, Plaintiffs alleged that the medical professional who prescribed Younce Paxil relied upon Paxil's label and prescriber information. Finally, Plaintiffs have alleged that S.Y. suffers from birth defects caused by taking Paxil while pregnant, which stems from her reliance on the alleged nonconforming representation. Taken together, the Court finds that Plaintiffs have sufficiently pled a claim under O.R.C. § 2307.77.
Am. Compl. ¶ 179.
Id. ¶ 63.
Id. ¶ 69-70, 181
D. Punitive Damages
In challenging Plaintiffs' ability to make a claim for punitive damages, GSK maintains that under Ohio law, it must be proven that a defendant acted with actual malice or stated differently, a "conscious disregard for the rights and safety of other persons that has a great probability of causing substantial harm." GSK argues that Plaintiffs have failed to offer any allegations concerning actual malice, and as a result, Plaintiffs' punitive damages claim fails as a matter of law. Plaintiffs retort that they have alleged that GSK knew or should have known about the dangers of Paxil and still marketed it to the general public. Plaintiffs assert they have pled sufficient facts to survive a motion to dismiss and is entitled to discovery on the punitive damages claim.
Def.'s Opening Br. at 14 (citing Preston v. Murphy, 512 N.E.2d 1174, 1176 (Ohio 1987)).
Id.
Pl.'s Opp'n Br. at 10-11.
Id. at 11.
Under the OPLA, drug manufacturers are exempt from punitive damages so long as the drug was manufactured, labeled, and marketed in accordance with FDA regulations. An exception exists if the drug manufacturer committed fraud against the FDA. State law fraud-on-the-FDA claims, however, have been preempted by the U.S. Supreme Court. Some federal courts have acknowledged that Ohio's exception may still apply "only if the FDA has made a finding of either fraud or misrepresentation." Here, Plaintiffs neither allege that GSK failed to follow FDA regulations in gaining approval to market Paxil nor that the FDA found that GSK had committed fraud in gaining approval of Paxil. Accordingly, it appropriate to dismiss Plaintiff's request for punitive damages under Ohio law.
Id. § 2307.80(C)(2).
Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341, 348 (2001) ("we hold that the plaintiffs' state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law."); see also Monroe, 29 F.Supp.3d at 1129-30 (discussing Buckman's effect on OPLA).
Johnson v. Eisai, Inc., 590 F.Supp.3d 1053, 1067 (N.D. Ohio Mar. 9, 2022); see also Monroe, 29 F.Supp.3d at 1130; In re Gadolinium-Based Contrast Agents Products Liability Litig., 2013 WL 587655, at *14 (N.D. Ohio Feb. 13, 2013).
IV. Conclusion
For the foregoing reasons, GSK's Motion to Dismiss as to Counts VII and IX is DENIED and GSK's Motion to Dismiss as to Counts I, II, III, IV, V, VI is GRANTED. Last, GSK's Motion as to Plaintiff's request for punitive damages is GRANTED.
IT IS SO ORDERED.